In the manufacture of sterile medical products, in particular filter modules/dialyzers, care must be taken to ensure that the product remains sterile until used on a patient or applied as part of a treatment. For this purpose, it must be ensured that either the sterile barrier is applied to the product itself or that the packaging forms a sterile barrier to the environment which remains intact for the shelf-life time shown on the product, assuming realistic storage conditions.
In terms of their external shape, filter modules/dialyzers are designed solely from the point of the demands of production and application technology. Obviously this shape creates particular demands in terms of the packaging of the filter module/dialyzer. An especially problematic feature of the packaging are the standardized, protruding and sharp-edged connectors on the filter module/dialyzer, edges on the filter module/dialyzer and protection caps on the filter module/dialyzer.
Known packagings for medical products, in particular for filter modules/dialyzers, primarily consist of a bag made of plastic or aluminium tube or a seal edge bag (as primary packaging), also a tray made of plastic, cardboard or molded pulp and if necessary an external box (as secondary packaging). The tray in particular has generally a shape, which substantially corresponds to the shape of the product packaged in the primary packaging, resulting in a kind of form fit which aims to achieve positionally stable packaging.
Some medical products, in particular filter modules/dialyzers, have to be sterilized in oxygen-free conditions where applicable. This means that at the time of sterilization, the inside of the primary packaging has to be (absolutely) oxygen-free. This is normally realized by absorption of the oxygen with a suitable medium, a so-called getter. The medium material can be iron powder or a polymer, for example. The absorber can be added to the primary packaging as a so-called sachet or integrated in the structure of the packaging material (foil).
It is a significant disadvantage that the binding of molecular oxygen in the closed system of the primary packaging results in a volume reduction or negative pressure (in an environment which does not change shape). Known packaging systems are not dimensionally stable, so that after closure of the packaging, their volume is uncontrollably reduced corresponding to the oxygen binding. Such a volume reduction of the primary packaging allows relative movements between the packaged filter modules/dialyzers among each other inside the secondary packaging as well as between the packaged filter modules/dialyzers and the secondary packaging, wherein this relative movements can in turn result in damage to the sterile barrier. Conventional trays and external boxes cannot respond to such a change or reduction in volume since they are rigid.
Another disadvantage of known packaging systems is that they are fixed in terms of the number of products they contain. This is all the more significant in view of the fact that filter modules/dialyzers are put on the market in different sizes so as to meet the need for differing volumes of blood of individual patients. Generally speaking it tends to be the diameter rather than the length of the component that is varied (for reasons relating to production and logistics). As the membrane surface is enlarged, the diameter of the component increases. Generally speaking, trays and external boxes with specific diameters are then required.
Finally, certain medical products such as filter modules/dialyzers are stored separately from the treatment room in day-to-day hospital routine. Hospital staff therefore regularly have to transport the products from a depot to a treatment room. Up to now, no aids have existed for this purpose. Staff have had to rely on their own solutions to carry out this transportation. At times this has resulted in the use of ineffective methods of transport which have often impaired the sterile barrier in the packaging.